Application 075955

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075955-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075955-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2002-10-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075955-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075955-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075955-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075955-001	AP	1	`ea99ee380514…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	51a88e8e-da02-4b97-9e7e-442fbffd908d	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Safecor Health LLC	f49d011f-5ca6-4f75-ba16-2099fe42f5aa	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	f3e631c5-1204-419c-8dbe-fa9b37a77f97	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	f4532f12-3b7a-42ab-9a6c-36fd2a3f192c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Dr. Reddy's Labratories Inc.	95cef33b-c0e6-b17c-7cbb-f5c066872705	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	4c149392-a4f0-4e2d-a13f-2b94810005de	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	337c5695-e3f8-41c6-a088-a492d5c60215	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	7bdc2236-3a1a-4210-a9fb-38f860227aa7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	352ed423-fc16-47bb-8e25-98e1c20f9991	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	7ccd3733-c3af-4a11-8500-0f99194c1472	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Aurobindo Pharma Limited	7ae393d1-7469-432a-9f21-f5ebab1207d1	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	e9151c1b-b70c-477b-868a-fffdc5c51830	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Zhejiang Poly Pharm. Co., Ltd.	0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	AvPAK	924c9359-ebc4-62a7-e053-2a95a90a4327	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	8377eb89-0d62-48c5-90e7-e96d545a4642	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	28cd0224-3569-4308-bd40-480bc4230503	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	ProPharma Distribution	364ab45e-b525-f310-e063-6394a90a4421	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Advagen Pharma Limited	d911b4cf-eec4-43f8-aa64-cc60cfc901b9	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39498	SUPPL	2013-08-23
23789	ORIG	2005-07-28